fialni bulk

English translation: final bulk

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Croatian term or phrase:finalni bulk
English translation:final bulk
Entered by: Mira Stepanovic

16:34 Oct 12, 2013
Croatian to English translations [PRO]
Chemistry; Chem Sci/Eng
Croatian term or phrase: fialni bulk
Testiranje sterilnosti fialnog bulka i gotovog proizvoda antitoksina za otrov europskih zmija (konjskog) otopine za injekciju provodi se prema metodi Ph. Eur. 07/2010 opisanoj u PKK. Navedena metoda je u potpunosti prema europskoj farmakopeji te je bilo potrebno provesti njezinu verifikaciju prema Ph. Eur. 07/2010.
bjuric2
Local time: 06:54
final bulk
Explanation:
http://www.bioreliance.com/sterilitytesting.aspx
BioReliance offers the following tests under GLP or GMP:
Direct Inoculation Sterility for Final Bulk
Direct Inoculation Sterility for Final Vials
---
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria respectively.

https://www.google.rs/search?q=final bulk&ie=utf-8&oe=utf-8&...

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Note added at 16 hrs (2013-10-13 09:30:48 GMT)
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Ph. Eur. = Pharmaeuropa
http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
(Pharmeuropa 22.3, 07/2010)
---
 Rabies vaccine : NIH potency assay performed on 1 out of 10 lots derived from one final bulk
---
• In vivo testing carried out on Final bulk products
(FBP) instead of Final products
---
• A final bulk/lot that is representative of the current production method

--------------------------------------------------
Note added at 1 day15 hrs (2013-10-14 08:28:22 GMT)
--------------------------------------------------

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
A.3.5.2.4 Sterility
The sterility test should be performed using at least 10 ml of each final bulk for bacterial and mycotic sterility, in accordance with the recommendations of Part A, section 5, of the revised General requirements for the sterility of biological substances (Requirements for biological substances, No. 6) (22), or by a method approved by the NRA.
---
A.3.5.2.5 Specific toxicity
Each final bulk is tested for specific toxicity in at least five guinea pigs, each weighing 250350 g, that have not been used previously for experimental purposes.
Selected response from:

Mira Stepanovic
Serbia
Local time: 06:54
Grading comment
Thank you
4 KudoZ points were awarded for this answer



Summary of answers provided
4final bulk
Mira Stepanovic
2vial bulk
lirka
Summary of reference entries provided
fialni bulk?
bonafide1313

Discussion entries: 1





  

Answers


2 hrs   confidence: Answerer confidence 2/5Answerer confidence 2/5
vial bulk


Explanation:
Perhaps, I am not sure this time...

lirka
Austria
Local time: 06:54
Native speaker of: Native in EnglishEnglish, Native in SlovenianSlovenian
Login to enter a peer comment (or grade)

16 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
final bulk


Explanation:
http://www.bioreliance.com/sterilitytesting.aspx
BioReliance offers the following tests under GLP or GMP:
Direct Inoculation Sterility for Final Bulk
Direct Inoculation Sterility for Final Vials
---
Sterility testing of unprocessed and final bulk, final vials, prebanking cells, and cell and virus banks is typically performed by directly inoculating the test article into 2 different types of media that support the growth of aerobic and anaerobic bacteria respectively.

https://www.google.rs/search?q=final bulk&ie=utf-8&oe=utf-8&...

--------------------------------------------------
Note added at 16 hrs (2013-10-13 09:30:48 GMT)
--------------------------------------------------

Ph. Eur. = Pharmaeuropa
http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
(Pharmeuropa 22.3, 07/2010)
---
 Rabies vaccine : NIH potency assay performed on 1 out of 10 lots derived from one final bulk
---
• In vivo testing carried out on Final bulk products
(FBP) instead of Final products
---
• A final bulk/lot that is representative of the current production method

--------------------------------------------------
Note added at 1 day15 hrs (2013-10-14 08:28:22 GMT)
--------------------------------------------------

http://www.google.rs/url?sa=t&rct=j&q=&esrc=s&source=web&cd=...
A.3.5.2.4 Sterility
The sterility test should be performed using at least 10 ml of each final bulk for bacterial and mycotic sterility, in accordance with the recommendations of Part A, section 5, of the revised General requirements for the sterility of biological substances (Requirements for biological substances, No. 6) (22), or by a method approved by the NRA.
---
A.3.5.2.5 Specific toxicity
Each final bulk is tested for specific toxicity in at least five guinea pigs, each weighing 250350 g, that have not been used previously for experimental purposes.

Mira Stepanovic
Serbia
Local time: 06:54
Specializes in field
Native speaker of: Native in SerbianSerbian, Native in Serbo-CroatSerbo-Croat
PRO pts in category: 16
Grading comment
Thank you
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Reference comments


7 hrs
Reference: fialni bulk?

Reference information:
http://www.proz.com/kudoz/english_to_russian/automation_robo...

http://www.patent-de.com/pdf/DE602004011553T2.pdf

ovo objašnjenje s ruskog možda bi moglo biti logičnije, a u prilog govori i ovaj patent, tj. da se radi o "bulk vial" ... nekoj bočici u kojoj se drži pripravak "u rinfuzi" ... "bulk vial" ima puno spominjanja na netu

... kako su ovi došli na "fialni bulk" ... fialna rinfuza, rinfuza u fiali?

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Note added at 7 hrs (2013-10-12 23:59:40 GMT)
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http://www.poslovni.hr/hrvatska/lijekovima-u-rinfuzi-ustedje...

bonafide1313
Croatia
Works in field
Native speaker of: Native in CroatianCroatian
PRO pts in category: 4
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